Methods and apparatus for delivering and positioning sheet-like materials in surgery

ABSTRACT

An implant delivery system for delivering a sheet-like implant is disclosed. The implant delivery system includes a distal guidewire port for receiving the proximal end of guidewire after the guidewire distal end has been affixed to a first point on bone or other tissue. The implant delivery system is tracked over the guidewire to a selected position defined by the guidewire attachment. The device includes an implant spreader assembly disposed proximate the distal end of a delivery shaft. The implant spreader assembly includes a first arm and a second arm. The arms are coupled to the delivery shaft such that the first arm and second arm are moveable between a closed position and an open position. When pivoting to the open position the distal end of each arm travels in a generally transverse direction to spread a sheet-like implant.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/722,796 filed on Dec. 20, 2012 entitled “METHODS AND APPARATUS FORDELIVERING AND POSITIONING SHEET-LIKE MATERIALS IN SURGERY”, whichclaims priority to U.S. Provisional Application No. 61/581,628 filed onDec. 29, 2011, the disclosure of each of which are incorporated byreference herein in their entirety.

The present disclosure is related to the following commonly assignedco-pending applications, the disclosures of which are incorporatedherein by reference: U.S. Application No. 61/443,169 Filed on Feb. 15,2011 now; U.S. Provisional Application No. 61/581,629, Attorney DocketNo. 10322-716.100, entitled, “GUIDEWIRE HAVING A DISTAL FIXATION MEMBERFOR DELIVERING AND POSITIONING SHEET-LIKE MATERIALS IN SURGERY,” filedon Dec. 29, 2011 and U.S. Provisional Application No. 61/581,631Attorney Docket No. 10322-717.100 entitled, “ANATOMICAL LOCATION MARKERSAND METHODS OF USE IN POSITIONING SHEET-LIKE MATERIALS DURING SURGERY”filed on Dec. 29, 2011.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention relates generally to orthopedic medicine andsurgery. More particularly, the present invention relates to methods andapparatus for positioning and delivering a sheet-like material to adesired location in treating tendons or like tissue such as tendons inthe rotator cuff of the shoulder.

BACKGROUND

The glenohumeral joint of the shoulder is found where the head of thehumerus mates with a shallow depression in the scapula. This shallowdepression is known as the glenoid fossa. Six muscles extend between thehumerus and scapula and actuate the glenohumeral joint. These sixmuscles include the deltoid, the teres major, and the four rotator cuffmuscles. The rotator cuff muscles are a complex of muscles. The musclesof the rotator cuff include the supraspinatus, the infraspinatus, thesubscapularis, and the teres minor. The centering and stabilizing rolesplayed by the rotator cuff muscles are critical to the proper functionof the shoulder. The rotator cuff muscles provide a wide variety ofmoments to rotate the humerus and to oppose unwanted components of thedeltoid and pectoral muscle forces.

The muscles of the rotator cuff arise from the scapula. The distaltendons of the rotator cuff muscles splay out and interdigitate to forma common continuous insertion on the humerus. The supraspinatus musclearises from the supraspinatus fossa of the posterior scapula, passesbeneath the acromion and the acromioclavicular joint, and attaches tothe superior aspect of the greater tuberosity. The mechanics of therotator cuff muscles are complex. The rotator cuff muscles rotate thehumerus with respect to the scapula, compress the humeral head into theglenoid fossa providing a critical stabilizing mechanism to the shoulder(known as concavity compression), and provide muscular balance. Thesupraspinatus and deltoid muscles are equally responsible for producingtorque about the shoulder joint in the functional planes of motion.

The rotator cuff muscles are critical elements of this shoulder musclebalance equation. The human shoulder has no fixed axis. In a specifiedposition, activation of a muscle creates a unique set of rotationalmoments. For example, the anterior deltoid can exert moments in forwardelevation, internal rotation, and cross-body movement. If forwardelevation is to occur without rotation, the cross-body and internalrotation moments of this muscle must be neutralized by other muscles,such as the posterior deltoid and infraspinatus. The timing andmagnitude of these balancing muscle effects must be preciselycoordinated to avoid unwanted directions of humeral motion. Thus thesimplified view of muscles as isolated motors, or as members of forcecouples must give way to an understanding that all shoulder musclesfunction together in a precisely coordinated way—opposing musclescanceling out undesired elements leaving only the net torque necessaryto produce the desired action. Injury to any of these soft tissues cangreatly inhibit ranges and types of motion of the arm.

With its complexity, range of motion and extensive use, a common softtissue injury is damage to the rotator cuff or rotator cuff tendons.Damage to the rotator cuff is a potentially serious medical conditionthat may occur during hyperextension, from an acute traumatic tear orfrom overuse of the joint. With its critical role in abduction,rotational strength and torque production, the most common injuryassociated with the rotator cuff region is a strain or tear involvingthe supraspinatus tendon. A tear at the insertion site of the tendonwith the humerus, may result in the detachment of the tendon from thebone. This detachment may be partial or full, depending upon theseverity of the injury or damage. Additionally, the strain or tear canoccur within the tendon itself. Injuries to the supraspinatus tendon andcurrent modalities for treatment are defined by the type and degree oftear. The first type of tear is a full thickness tear, which as the termindicates, is a tear that extends through the thickness of thesupraspinatus tendon regardless of whether it is completely tornlaterally. The second type of tear is a partial thickness tear which isfurther classified based on how much of the thickness is torn, whetherit is greater or less than about 50% of the thickness.

The accepted treatment for a full thickness tear or a partial thicknesstear greater than 50% includes reconnecting the torn tendon via sutures.For the partial thickness tears greater than 50%, the tear is completedto a full thickness tear by cutting the tendon prior to reconnection. Insome procedures, the surgeon will position a sheet-like patch over thesutured area to strengthen the repair and try to prevent the suturesfrom tearing through the tendon. The placement of the patch can beaccomplished readily in an open surgical procedure, however, placementand attachment of the patch in an arthroscopic procedure has been shownto be very difficult.

In contrast to the treatment of a full thickness tear or a partialthickness tear of greater than 50%, the current standard treatment for apartial thickness tear less than 50% usually involves physical cessationfrom use of the tendon, i.e., rest. Specific exercises can also beprescribed to strengthen and loosen the shoulder area. In manyinstances, the shoulder does not heal, and the partial thickness tearcan be the source of chronic pain and stiffness. Further, the pain andstiffness may cause restricted use of the limb which tends to result infurther degeneration or atrophy in the shoulder. Surgical interventionmay be required for a partial thickness tear of less than 50%, however,current treatment interventions do not include repair of the tendon, andrather the surgical procedure is directed to arthroscopic removal ofbone to relieve points of impingement or create a larger tunnel betweenthe tendon and bone that is believed to be causing tendon damage. Aspart of the treatment, degenerated tendon may also be removed using adebridement procedure in which tendon material is removed or ablated.Again, the tendon partial thickness tear is not repaired. Severalauthors have reported satisfactory early post-operative results fromthese procedures, but over time recurrent symptoms have been noted. Inthe event of recurrent symptoms, many times a patient will “live withthe pain”. This may result in less use of the arm and shoulder whichcauses further degeneration of the tendon and may lead to more extensivedamage. A tendon repair would then need to be done in a later procedureif the prescribed treatment for the partial tear was unsuccessful inrelieving pain and stiffness or over time the tear propagated throughinjury or degeneration to a full thickness tear or a partial thicknesstear greater than 50% with attendant pain and debilitation. A subsequentlater procedure would include the more drastic procedure of completingthe tear to full thickness and suturing the ends of the tendon backtogether. This procedure requires extensive rehabilitation, hasrelatively high failure rates and subjects the patient who firstpresented and was treated with a partial thickness tear less than 50% toa second surgical procedure.

As described above, adequate devices and methods for positioningsheet-like patches or implants during an arthroscopic procedure do notcurrently exist. It has been shown to be very difficult to properlyposition and attach a sheet-like implant unless the treatment site isaccessed in an open procedure. Further, adequate procedures do not existfor repairing a partial thickness tear of less than 50% in thesupraspinatus tendon. Current procedures attempt to alleviateimpingement or make room for movement of the tendon to prevent furtherdamage and relieve discomfort but do not repair or strengthen thetendon. Use of the still damaged tendon can lead to further damage orinjury. Prior damage may result in degeneration that requires a secondmore drastic procedure to repair the tendon. Further, if the priorprocedure was only partially successful in relieving pain anddiscomfort, a response may be to use the shoulder less which leads todegeneration and increased likelihood of further injury along with theneed for more drastic surgery. Therefore, it would be beneficial to beable to position, deliver and attach a sheet-like implant to a treatmentsite in an arthroscopic procedure. It would also be beneficial to treatpartial thickness tears greater than 50% without cutting the untornportion of the tendon to complete the tear before suturing backtogether. There is a large need for surgical techniques and systems toposition, deploy and attach implants during an arthroscopic procedureand to treat partial thickness tears and prevent future tendon damage bystrengthening or repairing the native tendon having the partialthickness tear.

SUMMARY OF THE DISCLOSURE

The disclosure is directed to an implant delivery system for accuratelypositioning and deploying or delivering a sheet-like implant. Oneembodiment provides an implant delivery system including an implantretainer assembly and an implant spreader assembly. The implant retainerassembly and the implant spreader assembly are provided proximate thedistal end of a delivery shaft. The implant retainer assembly isconfigured to releasably couple a sheet-like implant thereto forpositioning the sheet-like implant at a treatment site. The implantspreader assembly is configured to expand the sheet-like implant so thatthe sheet-like implant covers the treatment site.

The implant delivery system can include a distal guidewire port locatedproximate the distal end of the delivery system a fixed and knowndistance both laterally and longitudinally relative to an implant whenit is loaded onto the implant retainer assembly. With this embodiment,the implant delivery system can be included in a kit that includes aguidewire or be used in conjunction with a guidewire that is providedseparately from the implant delivery system. The guidewire can include aproximally extending length of wire that extends from a distal tissueretention member. The tissue retention member provides a temporaryconnection of the distal end of the guidewire to the bone or othertissue. The tissue retention member includes means for temporarily orreversibly fixing the distal end of the guidewire to tissue, such asbone. The means for affixing can include a K-wire (Kirshner wire) whichcan be a smooth stainless steel pin with a drill tip that cuts into bonewhen rotated. Alternatively, the means for fixing can include a screwthat is threaded or a fine pin that is hammered into bone or othertissue. The fine pin can include barbs or other projections and/orsurface texture that aid in temporarily fixing the distal end of theguidewire to the bone or other tissue. The proximally extending wire canbe coupled to the tissue retention member via a strain relief thatallows the wire to bend proximate the tissue retention member. Thestrain relief can include a spring or a coil.

The positional relationship (lateral and longitudinal) of a loadedimplant relative to the distal guidewire port is advantageously used toposition the implant delivery system relative to a first fixed point onthe anatomy of the patient and assures the deployed implant willproperly cover the treatment site. The first fixed point on the anatomycan be used as the location of the distal end of the guidewire as fixedto the bone or other tissue. The proximal end of the guidewire is fedthrough the distal guidewire port, and the delivery system is guided bythe wire to abut the anatomy or the tissue retention member proximatethe fixed point.

In one method of using the present system, a first fixed point isdetermined through observation and/or measurement of a treatment site ortissue to be covered by the implant relative to other anatomy. Forexample, in treating a rotator cuff injury, the surgeon can measure thesupraspinatus tendon lateral width and observe the location of the linegenerally defining the point of insertion of the tendon into the humeralhead. With these measurements known, along with the known size ofimplant to be used and the longitudinal/lateral location of the loadedimplant relative to the guidewire port, a best location for the firstfixed point can be selected and the guidewire fixed thereto.

Determining a first fixed point for the implant location, however, maynot adequately position the implant as it can be rotated, at least tosome degree, about that first fixed point. Therefore, in someembodiments, at least a second anatomical point or position isidentified and/or marked to assure the implant is rotated to properposition on the first fixed point. In some embodiments a thirdanatomical point or position may also be identified and/or marked, inwhich embodiment the second and third point can define a line which isgenerally parallel to an edge of the implant when properly rotated aboutthe first point. In treating the supraspinatus tendon, a marker can beplaced through the skin and tendon while viewing the articular side ofthe supraspinatus tendon where the biceps tendon is also visible. Themarker can be inserted adjacent the biceps tendon to delineate itslocation and assure the implant is rotated to generally parallel thebiceps tendon and avoid any staples attaching to such tendon which mayinterfere with its function.

In some exemplary embodiments, the implant spreader assembly includes afirst arm and a second arm each having a proximal and a distal end. Theproximal end of each arm is pivotably connected proximate the distal endof the delivery shaft. The first and second arms are moveable between aclosed position and an open position. When the first and second arms arein the closed position, the arms extend generally in the longitudinaldirection. When pivoting to the open position the distal end of each armtravels in a generally transverse direction to spread an implant thathas been positioned on the implant retainer assembly. When pivoting fromthe open position to the closed position, the first arm and the secondarm may travel in different planes.

In some exemplary embodiments, a sheath is disposed about the implantspreader assembly. The sheath is slidable in a direction generallyparallel to a longitudinal axis of the delivery shaft such that thesheath can be retracted proximally from around the implant spreaderassembly. The sheath can include a bullet nose distal end to easeinsertion into the shoulder space.

A sheet-like implant may be releasably coupled to the implant retainerassembly. When this is the case, the sheet-like implant may fit withinthe sheath when the implant spreader is in the closed position. Thesheet-like implant may then be expanded to cover a treatment site whenthe sheath is retracted and the implant spreader is opened. In someuseful embodiments, the sheet-like implant extends tautly between thearms of the implant spreader when the arms are in the open position. Thesheet-like implant may assume a rolled configuration when the implantexpander is in the closed position.

In some exemplary embodiments, the first arm and the second arm pivottransversely in different planes such that in the open position thesheet-like implant extending between the arms forms a generally curvedsurface to conform to a generally curved treatment site when placedthereon. In some instances, the first arm and the second arm pivottransversely in the same plane such that in the open position thesheet-like implant extending between the arms forms a generally flatsurface.

In some embodiments, the implant retainer assembly comprises a centerpost disposed proximate the distal end of the delivery shaft. A matingsurface having a longitudinally extending groove generally parallel andspaced from the center post cooperates with the center post to retainthe implant when it is slidably disposed therebetween. The center postand mating surface define a slot that is dimensioned to receive thesheet-like implant.

Another embodiment provides an implant delivery system including adelivery shaft having a proximal end and a distal end defining agenerally longitudinal direction. An implant spreader assembly isprovided proximate the distal end of the delivery shaft. A sheet-likeimplant is coupled to the implant spreader such that the implant isfolded when the arms of the implant spreader are in a closed positionand unfolded when the arms of the implant spreader are in an openposition. The implant spreader assembly may be used to unfold thesheet-like implant, for example, to spread the implant over a treatmentsite within the body. A hood that extends distally from the distal endof the shaft, generally parallel to the implant spreader assembly can beincluded. The hood is spaced radially from the implant retentionassembly and retains the implant in folded configuration when unsheatheduntil deployment of the implant spreader.

A method of treating a site such as a rotator cuff of a shoulder mayinclude the step of providing an implant delivery system as describedabove. The treatment site or shoulder of the patient may be inflated tocreate a cavity therein. The treatment site can be observed and/ormeasured using a probe or other instrument to identify the properimplant size and a first anatomical location for affixing the distal endof a guidewire such that abutment of the guidewire port proximate thislocation will place the implant at a desired location when deployed. Aguide wire is affixed to the anatomical location selected, as forexample, a point near the insertion of the supraspinatus tendon on thehumeral head. Further, a second and/or third anatomical point can beidentified that will give proper rotational position to the implantdelivery system. These points can be identified and markers placed toprovide a visual reference. The implant delivery system can be trackedover the guidewire to abut the first reference point. The implant andthe implant spreader assembly may be unsheathed inside the cavity. Theimplant may be spread over a target tissue at the treatment site androtated to align with the second and/or third reference points asmarked. The implant may be affixed to the target tissue. The implant maybe released from the implant delivery system. The implant spreaderassembly may be removed from the cavity. In some cases, the implantspreader assembly is assuming the closed configuration while the implantspreader assembly is withdrawn from the cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view illustrating an exemplary implant deliverysystem including an actuating handle assembly and a barrel;

FIG. 1B is a an alternative perspective view of the implant deliverysystem of FIG. 1A illustrating an implant retainer assembly and implantspreader assembly on a distal portion of the delivery system extendingbeyond the sheath;

FIG. 1C is a partial cross sectional view of the implant deliveryassembly of FIG. 1A depicting the actuating mechanism in the handleassembly;

FIG. 1D is a perspective view of the delivery shaft including theimplant spreader and implant retainer assemblies of FIG. 1B as removedfrom the sheath and handle;

FIG. 1E is an alternative perspective view of the implant deliverysystem of FIG. 1A illustrating details of the implant retainer assemblyand the location of a distal guidewire port;

FIG. 1F is a perspective view of an implant delivery system having aguidewire extending from a distal guidewire port;

FIG. 1G is a partial perspective view illustrating the distal portion ofthe implant delivery system of FIG. 1F, including an implant folded andmounted on the implant retainer assembly and a guidewire extending fromthe guidewire port;

FIG. 1H is partial perspective view illustrating the distal portion ofthe implant delivery system of FIG. 1F after activation of the implantspreader assembly to unfurl the implant;

FIG. 2A is a perspective view of a guidewire as disposed in a deliveryassembly for attachment to bone or other tissue;

FIG. 2B is a perspective view of the guidewire and sheath of FIG. 2Adepicting the sheath partially retracted as it would be removedproximally after attachment of the guidewire to bone or other tissue;

FIG. 2C is partial perspective view of the distal portion of theguidewire of FIG. 2B illustrating a sharpened drill point or K-wire tipfor penetrating bone and a strain relief connection to a proximal wireportion;

FIG. 2D is a perspective view of an alternative guidewire disposed in adelivery assembly having a distal screw that can be rotated by thesheath to attach to bone or other tissue;

FIG. 2E is a partial perspective view of another alternative guidewiredisposed in a sheath having a distal pin that can be hammered into boneor other tissue;

FIG. 3A is perspective view of a marker disposed in a needle-like sheathfor insertion into tissue to define a reference point;

FIG. 3B is a perspective view of the marker of FIG. 3A as removed fromthe needle-like sheath;

FIG. 3C is a partial perspective view of the distal portion of themarker of FIG. 3B illustrating a plurality of distal arms extendinglongitudinally as they would be when constrained within the sheath;

FIG. 3D is a partial perspective view of the arms of FIG. 3C as deployedupon removal of the sheath to extend laterally and retain the marker intissue;

FIG. 4A is a perspective view of an exemplary probe used to observe andmeasure tissue in a treatment site;

FIG. 4B is a partial perspective view of the distal portion of the probeof FIG. 4A;

FIG. 5 is a stylized anterior view of a patient with the shoulder beingshown in cross-section for purposes of illustration;

FIG. 6 is a stylized view of a shoulder depicting the head of thehumerus shown mating with the glenoid fossa of the scapula at aglenohumeral joint and a sheet-like material is affixed to the tendon;

FIG. 7A is a stylized perspective view showing a portion of the body ofa human patient divided into quadrants by planes for descriptivepurposes;

FIG. 7B is a stylized perspective view illustrating an exemplaryprocedure for arthroscopic treatment of a shoulder of a patient inaccordance with one embodiment of the disclosure;

FIG. 8A is a perspective view of a portion of the shoulder with partsremoved to illustrate the supraspinatus tendon in relation to otheranatomical features;

FIG. 8B is a partial perspective view of the articular side of thesupraspinatus tendon illustrating the position relative to the bicepstendon and a marker inserted from the bursal side to identify thelocation of the biceps tendon which is not visible from the bursal side;

FIG. 8C is another partial perspective view of the articular side of thesupraspinatus tendon as shown in FIG. 8B with a second marker insertedto delineate the biceps tendon over its length which is not visible fromthe bursal side;

FIG. 8D is a partial perspective view of the shoulder showing the twomarkers of FIG. 8C as they extend proximally from a point of insertionin the skin;

FIG. 8E is a partial perspective view of the shoulder of FIG. 8D withthe inclusion of two portal incisions made relative to the markers;

FIG. 8F is a partial perspective view of the shoulder of FIG. 8Adepicting the two markers from the bursal side of the tendon as theyextend therethrough and would be seen during arthroscopic placement ofan implant;

FIG. 8G is a partial perspective view of the shoulder of FIG. 8Fillustrating the placement of a guidewire relative to the markers;

FIG. 8H is a partial perspective view illustrating a guidewire asaffixed to bone relative to the markers;

FIG. 8I is a partial perspective view of the shoulder of FIG. 8H with animplant delivery system distal sheath illustrated as guided over thewire;

FIG. 8J is a partial perspective view of the shoulder of FIG. 8Iillustrating the extension of an implant retention assembly from thesheath;

FIG. 8K is a partial perspective view of the shoulder of FIG. 8Jillustrating the deployment of an implant spreader assembly andpositioning of the implant relative to the markers;

FIG. 8L is a partial perspective view of the shoulder of FIG. 8Kdepicting partial retraction of the implant delivery system as theimplant is affixed by staples to the tendon;

FIG. 8M is a partial perspective view of the shoulder of FIG. 8Ldepicting the closing of the implant spreader assembly in conjunctionwith removal from the shoulder; and

FIG. 8N is a partial perspective view of the shoulder of FIG. 8Mdepicting removal of the guidewire attachment from the shoulder prior toaffixing the proximal portion of the implant to the humeral head.

DETAILED DESCRIPTION

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

The present disclosure is directed to an implant delivery system that isparticularly useful for accurately positioning and deploying ordelivering a sheet-like implant to a treatment Site. The delivery systemis discussed in detail with respect to treatment of tendons inarticulating joints, specifically the supraspinatus tendon of therotator cuff in the shoulder. However, it is recognized that thedelivery system and other components of a kit disclosed herein can beutilized in any areas of the body wherein it is desired to accuratelyposition a sheet-like implant, especially during an arthroscopicprocedure where access and visibility are limited.

The implant delivery system can be used in conjunction with a guidewireor be part of a kit that includes a guidewire. The guidewire isconfigured with a distal end that attaches to bone or other tissue at afirst fixed point that is determined through observation and measurementof the treatment site. The first fixed point is determined based onknowledge of the size of the implant to be used, the known location of adistal guidewire port on the delivery system relative to an implant whenit is loaded on the delivery system and the measured/observed anatomy ofthe treatment site. Once the guidewire is attached at the first fixedpoint, the delivery system can track over the wire to the properposition for delivering the implant. Details of the guidewire design aredisclosed with respect to the discussion of FIG. 2A-2E. The abovemethod, as applied to treatment of the supraspinatus tendon of therotator cuff is described in detail with respect to FIGS. 8A-8N.

The delivery system of this disclosure can also be used in conjunctionwith other tissue position markers or included in a kit with tissueposition markers. Identifying a first fixed point for attachment of theguidewire may not be sufficient in some applications to accuratelyposition the implant as the delivery system can be rotated to somedegree about the first point. By using visual observation and/or othermeasurement techniques a second, and if necessary a third, fixed pointcan be identified and marked with the markers to be used as a referencepoint or line for proper rotation or orientation of the implant aspositioned over the wire. The markers are described in detail withrespect to FIGS. 3A-3D and the method of marking a second and thirdfixed point are described for the rotator cuff with respect to FIGS.8A-8N.

Referring now to FIG. 1A, a perspective view of an exemplary implantdelivery system 60 is shown. Implant delivery system 60 includes ahandle assembly 100 and barrel assembly 102. As depicted in FIG. 1A, theouter barrel assembly 102 is a sheath 103 attached to and extendingdistally from the handle assembly 100. The sheath 103 can include abullet nose or tapered distal tip to aid in inserting the deliverysystem 60 through an incision to the treatment site. The sheath 103covers a delivery assembly as discussed with respect to FIG. 1B below.The sheath 103 of implant delivery system 60 is coupled to the handleassembly 100 in a fixed position, in the embodiment depicted. Inalternative embodiments the sheath 103 may be reciprocally engaged bythe handle assembly 100 to allow longitudinal movement in response tomovement of the trigger 105. The sheath can be opaque, transparent oranywhere between. In some embodiments, at least a distal portion of thesheath is transparent so that an implant loaded within the sheath can beinspected for condition and observed as to how the implant is foldedwithin the lumen.

As depicted in FIG. 1B, the handle assembly 100 includes a body 107 andreciprocating trigger 105 attached thereto. The handle assembly alsoincludes a first button 111 that releasably engages a delivery shaft 130(discussed below with respect to FIG. 1D). The first button 111 allowsmovement of the delivery shaft 130 to extend beyond the sheath 103 forloading an implant and reverse movement pulls the delivery shaft 130back into the sheath 103.

A second button 109 is connected to longitudinal members that extendwithin the sheath to move arms of an implant spreader assembly 124 (seeFIG. 1B). Pushing of the button releases engagement with thelongitudinal members and allows the arms to close as the overall systemis pulled from the implant site.

FIG. 1B depicts the implant delivery system 60 of FIG. 1A with adelivery shaft 130 extended distally beyond the sheath 103 as would bedone during delivery of an implant. The extended delivery shaft 130 alsoallows visualization of the working components on the distal end of thedelivery system. These include an implant retainer assembly 148, animplant spreader assembly 124 and a hood 149. To better visualize theextension of the delivery shaft 130 relative to the handle assembly 100.FIG. 1C depicts the delivery system of FIG. 1B with a portion of thebody 107 removed to expose the linkages between the trigger 105, firstbutton 111 and second button 109 with the barrel assembly 102. Asillustrated, in this representative embodiment, the sheath 103 isrigidly fixed to a distal portion of the handle 100 with the deliveryshaft 130 slidably disposed therein. The delivery shaft is linked to afirst member 141 which is also linked to both the trigger 105 and firstpush button 111. Distal movement of the first push member 141, whetherby movement of the trigger 105 or the push button 109 being moveddistally causes distal extension of the delivery shaft 130 relative tothe sheath 103.

With reference to FIG. 1D, the delivery shaft 130 is depicted in moredetail as removed from the sheath 103 and disconnected from the handleassembly 100. The delivery shaft 130 includes a pair of longitudinallyextending members 143 that are operably connected to the tissue spreaderassembly 124. Linkage (not shown) within the handle assembly 100connects the proximal portion of the longitudinally extending members143 such that pulling on the trigger after the delivery shaft 130 hasbeen extended causes distal movement of the longitudinally extendingmembers 143 to operate the spreader assembly 124. One of skill in theart will recognize that the mechanisms described are representative ofone working embodiment of a handle coupled to the barrel assembly 102and that other actions and linkages can be used to operate the workingportions of the implant delivery system 60, to include both extension ofthe delivery shaft or retraction of the sheath and also deployment ofthe spreader assembly.

As best seen in FIG. 1E, a first arm 120 and a second arm 122 can beseen extending distally from the delivery shaft 130. First arm 120 andsecond arm 122 are both part of an implant spreader assembly 124.Implant spreader assembly 124 may be used to carry a sheet-like implantto a location within the human body. Implant spreader assembly 124 mayalso be used to unfold the sheet-like implant so that the sheet-likeimplant covers a treatment site within the body.

In the exemplary embodiment of FIG. 1E, first arm 120 and second arm 122are disposed in an open position. First arm 120 and second arm 122 arecapable of moving between the open position where the arms extendlaterally and a closed position wherein the arms generally extendlongitudinally parallel to the delivery shaft 130. When pivoting to theopen position the arms rotate so that distal end 128A of first arm 120and distal end 128B of second arm 122 move away from each other ingenerally transverse or lateral directions. In some embodiments thedistal ends of the arms lie in the same plane as the sheath in both theopen and closed positions, however, in other embodiments disclosedherein, the arms may move in different planes relative to each other sothat the implant will take a curved shape in the open position to betterconform to the treatment site as laterally delivered. Further, in somealternative embodiments, one arm may be stationary while the otherrotates to spread the implant.

As also shown in greater detail in FIG. 1E, the implant delivery system60 also includes an implant retainer assembly 148 located near a distalend of delivery shaft 130. In the exemplary embodiment of FIG. 1E,implant retainer assembly 148 comprises a center post 150 post disposedproximate the distal end of the delivery shaft 130 that cooperates witha mating surface 152 having a longitudinally extending groove 154generally parallel and spaced from the center post wherein the matingsurface and center post foi in a slot therebetween to retain the implantwhen it is slidably disposed thereon.

As also indicated on FIG. 1E, the implant delivery system includes aguidewire port 170 located proximate the distal end of the deliveryshaft 130. The guidewire port 170 is sized for receiving a proximal endof a guidewire, discussed below with respect to FIGS. 2A-2E,therethrough. The guidewire port location is positioned in knownrelation to an implant on the implant retainer assembly so that trackingthe implant delivery system over the guidewire to a known guidewirelocation fixes the location to which the implant will be deliveredrelative thereto.

FIG. 1F depicts the implant delivery system of FIG. 1A with a guidewire172 having been fed from a proximal end thereof through the guidewireport 170 and extending distally from the end of the barrel 102. Theinterior of the delivery shaft provides a lumen for receiving theproximal portion of the guidewire as it is fed through the guidewireport 170. As depicted, the guidewire 172 includes a tissue retentionmember 180 on the distal end thereof. In use, the tissue retentionmember 180 is affixed to bone or other tissue at a desired anatomicallocation. The implant delivery system 60 is then tracked over theguidewire from its proximal end until the distal end of the implantdelivery system (after the delivery shaft is extended from the sheath)or delivery shaft abuts the tissue or guidewire proximate the point atwhich the guidewire is fixed to the bone or other tissue.

The relationship between the implant delivery system 60, the guidewire172 and a sheet-like implant 50 mounted thereon for delivery can bebetter understood, in an exemplary embodiment, by reference to FIG. 1G.FIG. 1G depicts a distal portion of the delivery system with thedelivery shaft extended beyond the sheath. A sheet-like implant 50 isheld in place by the implant retention member 148 as previouslydescribed. Further, the implant 50 is shown in a folded configuration asit would fit in the sheath and remains in this configuration when thedelivery shaft is extended because a hood 149 is included in thisembodiment for receiving the edges of the implant 50 thereunder. Theguidewire 172 is depicted extending distal of the implant. In use, thedelivery shaft would be fed further distal over the guidewire until theball 181 is in contact or nearly in contact with the guidewire port atthe distal end of the delivery shaft, which is generally about 5 mm.distal of the proximal end of the implant or in alternative embodimentsmay be in longitudinal alignment with the proximal end of the implant.The guidewire port is also generally in lateral alignment with thecenter of the implant. Thus, the location of the attachment of theguidewire will generally conform to a location 5 mm. distal of theproximal end of the implant and at the lateral center of the implantwhen delivered in this embodiment. Other spacing could be used ifdesired, with the longitudinal and lateral relationship of the implantrelative to the guidewire port being known.

FIG. 1H depicts the distal portion of the implant delivery systemillustrated in FIG. 1G after the implant spreader assembly 124 isdeployed. As shown, the lateral movement of the arms 120, 122 pull theedge of the implant out from under the hood 149 and cause the implant 50to lay flat. The implant retention member 148 continues to hold theimplant on the assembly in order to allow movement of the implant to adesired position.

Referring now to FIG. 2A, a representative guidewire 172 and deliverysystem 200 is illustrated. The delivery system can include a shaft 202having a lumen 203 extending therethrough. The proximal end of the shaftincludes means for holding and directing the shaft 204 and the proximalend of the shaft can be attached to a rotating tool (not shown). Theguidewire 172 extends through the shaft lumen. The shaft furtherincludes mean for rotational engagement between the delivery system andthe guidewire. When inserted in the lumen, the guidewire rotates as theshaft rotates. Means for rotational engagement between the shaft andguidewire are generally known, as for example, a keyed portion near thedistal end of the guidewire may engage a mating surface extending fromthe shaft.

As depicted in FIG. 2B, the distal end of the guidewire includes atissue retention member 182 extending from a ball 181. In the embodimentshown, the tissue retention member can be a wire having a drill point ora K-wire (Kirshner wire) which includes a shaft or pin portion having asharpened distal end 183, much like a drill bit. Positioning the distalend 183 at a selected site on bone and rotating with some pressureapplied causes the guidewire to auger into the bone and become affixedat that point. FIG. 2B shows the guidewire with the delivery systembeing retracted proximally over the guidewire as would be done after thedistal tip of the guidewire is embedded in tissue. A strain relief 190is also visible.

Referring to FIG. 2C, a closer view of the distal portion of theguidewire 172 is illustrated. The K-wire distal tip includes sharpenededges 185 for cutting into bone or other tissue. Further, the strainrelief 190 is shown attached to the weld ball in the form of a spring orcoil having the guidewire 172 proximal portion extending from and/orattached to the spring. This configuration allows significant bending ofthe wire at the spring to allow the delivery system to be tracked tonear the ball 181 when in use. The spring also acts as a stop for theimplant delivery system when the guidewire port abuts the proximal endof the spring.

An alternative embodiment of a guidewire and guidewire delivery systemis depicted in FIG. 2D. The embodiment is similar to the above describedsystem, however, the tissue retention member 182, 183 is a screw. Astrain relief 190 is affixed to the proximal end of the screw and theproximal portion of the guidewire 172 is attached to and extends fromthe strain relief 190. As illustrated, the guidewire delivery system isessentially a screwdriver with a hollow shaft 202 for receiving theguidewire therein. A distal portion of the hollow shaft 202 engages thehead of the screw and a hand can be used to rotate the screw as itaugers into bone or other tissue.

FIG. 2E depicts another alternative guidewire and guidewire deliverysystem. In this embodiment, the distal end of the guidewire 172 includesa pin 210 that has a distal point 212. The pin has a proximal endattached to a strain relief 190 to which the proximal guidewire portionis attached extending proximally therefrom. The delivery shaft 202 isdesigned to abut the proximal end of the pin 210 and the system can thenbe hammered or otherwise forced into bone or other tissue to affix thepin thereto.

As previously disclosed, embodiments of the implant delivery systemdisclosed herein can be used in conjunction with tissue markers thatvisually identify anatomical locations at or near a treatment site toassist in proper placement of the implant with the implant deliverysystem. FIGS. 3A-3D detail one embodiment of a tissue marker system 300.Multiple markers can be used in a given procedure.

Referring first to FIG. 3A, a tissue position marker system 300 isdepicted. The tissue marker system 300 includes a delivery sleeve 302having a lumen 304 therethrough. The delivery sleeve can be aneedle-like shaft having a tissue penetrating distal end. A tissuemarker 308 is slidably disposed within the lumen 304 of the deliverysleeve 302. The tissue marker 308, in this embodiment has an elongatedshaft defining a longitudinal direction. A proximal handle, including afirst part 306 and second part 310 are coupled to the tissue marker anddelivery sleeve. The second part 310 of the proximal handle can bereleasably attached to the tissue marker 308 proximal end so that thesecond part can be removed to allow the delivery sleeve 302 to beremoved proximally over the tissue marker after it is affixed to tissue.The second part 310 can then be re-attached to the proximal end of themarker to aid in removing the marker after the procedure is completed.

FIG. 3B depicts the marker 308 as removed from the delivery sleeve 302.The distal portion of the marker 308 includes a plurality oflongitudinally extending arms 312 which are formed into the marker 308or attached to the distal end of the marker. These arms 312 are betterdepicted in the illustrations of FIGS. 3C and 3D. When unconstrained, aswhen the arms 312 are outside of the lumen of the delivery sleeve, theflexible arms project outward from the shaft proximate a distal endthereof, as shown in FIG. 3D. However, when the marker 308 is within thedelivery sleeve 302, the lumen walls flex and constrain the arms toextend generally longitudinally and fit therein. In the deployed stateoutside the delivery sleeve 302, the arms retain the marker's positionin tissue, yet can be pulled out without any significant effect on thetissue because the arms will flex to extend generally longitudinally asthey are pulled through the tissue. In some embodiments, the arms areflexible nitinol members and the marker can include at least three, andtypically four or more arms. The proximal handle can also include meansfor selectively coupling and decoupling the tissue marker and deliverysleeve to allow easier insertion of the combined assemblies into tissue.

As previously disclosed, the systems and devices disclosed herein areused in procedures that can be performed arthroscopically. To bettermake use of these systems and devices a surgeon can observe, probe andmeasure features of a treatment site visually to best identify the rightimplant and fixed locations for placing both the guidewire and/ormarkers for accurate delivery of the implant. An exemplary probe andmeasuring tool 350 is depicted in FIGS. 4A and 4B. The probe includes anelongate shaft 352 having a tapered distal portion 354. The tapereddistal portion terminates in a hook-shaped distal end 356. Further, theshaft can include ruled markings that can readily be viewed to measureany distance near the treatment site. The probe can be particularlyuseful in identifying the line of the point of insertion on thesupraspinatus tendon to the humeral head by inserting the probe on thearticular side of the tendon. The width of the tendon can also bemeasured in this way for selecting a proper implant size. The probedisclosed is one example of a tool to assist in identifying anatomicalpoints for placement of a guidewire, markers and a delivery system. Itis recognized that other tools can be utilized with the delivery system.

Next referring to FIG. 5, an exemplary use or application of the implantdelivery system of the present disclosure is described. FIG. 5 is astylized anterior view of a patient 20. For purposes of illustration, ashoulder 22 of patient 20 is shown in cross-section in FIG. 5. Shoulder22 includes a humerus 14 and a scapula 12. In FIG. 5, a head 24 ofhumerus 14 can be seen mating with a glenoid fossa of scapula 12 at aglenohumeral joint. The glenoid fossa comprises a shallow depression inscapula 12. The movement of humerus 14 relative to scapula 12 iscontrolled by a number of muscles including: the deltoid, thesupraspinatus, the infraspinatus, the subscapularis, and the teresminor. For purposes of illustration, only the supraspinatus 26 is shownin FIG. 5.

With reference to FIG. 5, a distal tendon 28 of the supraspinatus 26meets humerus 14 at an insertion point. Scapula 12 of shoulder 22includes an acromion 32. A subacromial bursa 34 is shown extendingbetween acromion 32 of scapula 12 and head 24 of humerus 14. Subacromialbursa 34 is shown overlaying supraspinatus 26 as well as supraspinatustendon 28 and a portion of humerus 14. Subacromial bursa 34 is one ofthe hundreds of bursae found the human body. Each bursa comprises afluid filled sac. The presence of these bursae in the body reducesfriction between bodily tissues.

The exemplary implant delivery system described herein may be used toposition and deploy sheet-like implants to various target tissuesthroughout the body. The shoulder depicted in FIG. 5 is one examplewhere a tendon repair implant may be affixed to one or more bonesassociated with an articulating joint, such as the glenohumeral joint.Additionally, the tendon repair implant may be affixed to one or moretendons to be treated. The tendons to be treated may be torn, partiallytorn, have internal micro-tears, be untorn, and/or be thinned due toage, injury or overuse. Applicants believe that the methods andapparatus of the present application and related devices may providevery beneficial therapeutic effect on a patient experiencing joint painbelieved to be caused by partial thickness tears and/or internalmicrotears. By applying a tendon-repair implant early before a full tearor other injury develops, the implant may cause the tendon to thickenand/or at least partially repair itself, thereby avoiding more extensivejoint damage, pain, and the need for more extensive joint repairsurgery.

FIG. 6 is a stylized anterior view of a shoulder 22 including a humerus14 and a scapula 12. In FIG. 6, a head 24 of humerus 14 is shown matingwith a glenoid fossa of scapula 12 at a glenohumeral joint. Asupraspinatus 26 is also shown in FIG. 6. This muscle, along withothers, controls the movement of humerus 14 relative to scapula 12. Adistal tendon 28 of supraspinatus 26 meets humerus 14 at an insertionpoint 30.

As depicted in FIG. 6, distal tendon 28 includes a first damaged portion36. A number of loose tendon fibers 40 in first damaged portion 36 arevisible in FIG. 6. First damaged portion 36 includes a first tear 42extending partially through distal tendon 28. First tear 42 maytherefore be referred to as a partial thickness tear. With reference toFIG. 6, first tear 42 begins on the side of distal tendon 28 facing thesubacromial bursa (shown in the previous Figure) and ends midway throughdistal tendon 28. Accordingly, first tear 42 may be referred to as abursal side tear.

With reference to FIG. 6, distal tendon 28 includes a second damagedportion 38 located near insertion point 30. As illustrated, seconddamaged portion 38 of distal tendon 28 has become frayed and a number ofloose tendon fibers 40 are visible. Second damaged portion 38 of distaltendon 28 includes second tear 44. Second tear 44 begins on the side ofdistal tendon 28 facing the center of the humeral head 24. Accordingly,second damaged portion 38 may be referred to as an articular side tear.

FIG. 6 illustrates a sheet-like implant 50 has been placed over thebursal side of distal tendon 28. The sheet-like implant 50 is affixed todistal tendon 28 by a plurality of tendon staples 51. Sheet-like implant50 is affixed to humerus 14 by a plurality of bone staples 100.Sheet-like implant 50 extends over insertion point 30, first tear 42 andsecond tear 44. Some useful methods in accordance with this detaileddescription may include placing a tendon repair implant on the bursalside of a tendon regardless of whether the tears being treated are onthe bursal side, articular side or within the tendon. In some cases theexact location and nature of the tears being treated may be unknown. Atendon repair implant may be applied to the bursal side of a tendon totreat shoulder pain that is most likely caused by one or more partialthickness tears in the tendon.

FIG. 7A is a stylized perspective view showing a portion of the body 82of a human patient 20. Body 82 includes a shoulder 22. In the exemplaryembodiment of FIG. 7A, a plurality of cannulas is positioned to access atreatment site within shoulder 22. In some cases, shoulder 22 may beinflated by pumping a continuous flow of saline through shoulder 22 tocreate a cavity proximate the treatment site. The cannulas shown in FIG.7A include a first cannula 80A, a second cannula 80B and a third cannula80C.

In FIG. 7A, a sagital plane SP and a frontal plane FP are shownintersecting body 82. Sagital plane SP and frontal plane FP intersectone another at a medial axis MA of body 82. With reference to FIG. 7A,sagital plane SP bisects body 82 into a right side 84 and a left side86. Also with reference to FIG. 7A, frontal plane FP divides body 82into an anterior portion 92 and a posterior portion 88. Sagital plane SPand a frontal plane FP are generally perpendicular to one another. Theseplanes and portions are used to describe the procedures used inexemplary embodiments.

First cannula 80A is accessing a treatment site within shoulder 22 usinga lateral approach in which first cannula 80A pierces the outer surfaceof right side 84 of body 82. The term lateral approach could also beused to describe situations in which an instrument pierces the outersurface of left side 86 of body 82. Second cannula 80B is accessing atreatment site within shoulder 22 using a posterior approach in whichsecond cannula 80B pierces the outer surface of posterior portion 88 ofbody 82. Third cannula 80C is accessing a treatment site within shoulder22 using an anterior approach in which third cannula 80C pierces theouter surface of anterior portion 92 of body 82.

FIG. 7B is a stylized perspective view illustrating an exemplaryprocedure for treating a shoulder 22 of a patient 20. The procedureillustrated in FIG. 7B may include, for example, fixing tendon repairimplants to one or more tendons of shoulder 22. The tendons treated maybe torn, partially torn, have internal micro-tears, be untorn, and/or bethinned due to age, injury or overuse.

Shoulder 22 of FIG. 7B has been inflated to create a cavity therein. Afluid supply 52 is pumping a continuous flow of saline into the cavity.This flow of saline exits the cavity via a fluid drain 54. A camera 56provides images from inside the cavity. The images provided by camera 56may be viewed on a display 58.

Camera 56 may be used to visually inspect the tendons of shoulder 22 fordamage. A tendon repair implant in accordance with this disclosure maybe affixed to a bursal surface of the tendon regardless of whether thereare visible signs of tendon damage. Applicants believe that the methodsand apparatus of the present application and related devices may providevery beneficial therapeutic effect on a patient experiencing joint painbelieved to be caused by internal microtears, but having no clear signsof tendon tears. By applying a tendon repair implant early before a fulltear or other injury develops, the implant may cause the tendon tothicken and/or at least partially repair itself, thereby avoiding moreextensive joint damage, pain, and the need for more extensive jointrepair surgery.

An implant delivery system 60 can be seen extending from shoulder 22 inFIG. 7B. Implant delivery system 60 is extending through a first cannula80A. In certain embodiments, first cannula 80A can access a treatmentsite within shoulder 22 using a lateral approach in which first cannula80A pierces the outer surface of a right side of the patient's body. Insome cases a physician may choose not to use a cannula in conjunctionwith implant delivery system 60. When that is the case, the implantdelivery system may be advanced through tissue. Implant delivery system60 comprises a sheath that is affixed to a handle. The sheath defines alumen and a distal opening fluidly communicating with the lumen. In theembodiment of FIG. 7B, the distal opening of the sheath has been placedin fluid communication with the cavity created in shoulder 22.

A tendon repair implant is at least partially disposed in the lumendefined by the sheath of implant delivery system 60. Implant deliverysystem 60 can be used to place the tendon repair implant inside shoulder22. In some embodiments, the tendon repair implant is folded into acompact configuration when inside the lumen of the sheath. When this isthe case, implant delivery system 60 may be used to unfold the tendonrepair implant into an expanded shape. Additionally, implant deliverysystem 60 can be used to hold the tendon repair implant against thetendon.

The tendon repair implant may be affixed to the tendon while it is heldagainst the tendon by implant delivery system 60. Various attachmentelements may be used to fix the tendon-repair implant to the tendon.Examples of attachment elements that may be suitable in someapplications include sutures, tissue anchors, bone anchors, and staples.In the exemplary embodiment of FIG. 7B, the shaft of a fixation tool 70is shown extending into shoulder 22. In one exemplary embodiment,fixation tool 70 is capable of fixing the tendon repair implant to thetendon and bone with one or more staples while the tendon repair implantmay be held against the tendon by implant delivery system 60.

As previously stated, the implant delivery system 60 can be used todeliver any sheet-like implant. A tendon repair implant 50 may comprise,for example, various sheet-like structures without deviating from thespirit and scope of the present detailed description. In some usefulembodiments, the sheet-like structure may comprise a plurality offibers. The fibers may be interlinked with one another. When this is thecase, the sheet-like structure may comprise a plurality of aperturescomprising the interstitial spaces between fibers. Various processes maybe used to interlink the fibers with one another. Examples of processesthat may be suitable in some applications including weaving, knitting,and braiding. In some embodiments, the sheet-like structure may comprisea laminate including multiple layers of film with each layer of filmdefining a plurality of micro-machined or formed holes. The sheet-likestructure of the tendon repair implant may also comprise a reconstitutedcollagen material having a porous structure. Additionally, thesheet-like structure of the tendon repair implant may also comprise aplurality of electro-spun nanofiber filaments forming a composite sheet.Additionally, the sheet-like structure may comprise a synthetic spongematerial that defines a plurality of pores. The sheet-like structure mayalso comprise a reticulated foam material. Reticulated foam materialsthat may be suitable in some applications are available from BiomerixCorporation of Fremont, Calif. which identifies these materials usingthe trademark BIOMATERIAL™. The sheet-like structure may be circular,oval, oblong, square, rectangular, or other shape configured to suit thetarget anatomy. Various attachment elements may be used to fix tendonrepair implant 50 to distal tendon 28 without deviating from the spiritand scope of this detailed description. Examples of attachment elementsthat may be suitable in some applications include sutures, tissueanchors, bone anchors, and staples. In the embodiment of FIG. 6,sheet-like implant 50 is affixed to distal tendon 28 by a plurality oftendon staples 51. Sheet-like implant 50 is affixed to humerus 14 by aplurality of bone staples 52. Details of exemplary tendon staples may befound in commonly assigned co-pending applications: U.S. applicationSer. No. 12/684,774 filed Jan. 8, 2010; U.S. application Ser. No.12/729,029 filed Mar. 22, 2010; U.S. application Ser. No. 12/794,540filed Jun. 4, 2010; U.S. application Ser. No. 12/794,551 filed on Jun.4, 2010; U.S. application Ser. No. 12/794,677 filed on Jun. 4, 2010; andU.S. Application No. 61/443,180 filed on Feb. 15, 2011, the disclosuresof which are incorporated herein by reference. Exemplary bone staplesare described in commonly assigned co-pending applications: U.S.Application No. 61/577,626 filed Dec. 19, 2011; U.S. Application No.61/577,632 filed Dec. 19, 2011 and U.S. Application No. 61/577,635 filedDec. 19, 2011, the disclosures of which are incorporated herein byreference. Exemplary staples in many of the above applications may beused for anchoring in both soft tissue and in bone.

Referring to FIGS. 8A-8N, a series of step-wise illustrations areprovided of exemplary use of the markers, guidewire and implant deliverysystem as an overall kit for treatment of the supraspinatus tendon ofthe shoulder. The supraspinatus tendon is used to illustrate one use ofthe system which may be adapted for use in other areas of the body, asone of skill in the art will readily recognize. In particular, thesystem is useful in areas of the body requiring accurate placement ofthe implant relative to other anatomical structures as the system isguided to a marked first position by the guidewire and rotated to properorientation relative to at least one, and at times two other markers ofanatomical structure.

Referring now to FIG. 8A, a shoulder 22 is schematically illustratedwith skin and other obstructing tissue removed so that the humerus 14and supraspinatus tendon 28 are readily visible for purposes of betterunderstanding exemplary procedures using the devices and methods of thecurrent disclosure. The humerus 14 and supraspinatus tendon 28 are shownin relation to clavicle 21 and acromion 23. Further, the infraspinatustendon 25 and teres minor tendon 27 are shown as they attach to thehumerus, and as previously stated, interdigitate with the supraspinatus.The point of insertion 30 of the supraspinatus tendon 28 to humeral head24 is also indicated and generally forms a line. The biceps tendon 29can be seen as it extends down the arm, however, this tendon is notvisible from this bursal side view on the rotator cuff of the shoulderas the biceps tendon 29 passes underneath the supraspinatus tendon andruns on the articular side of the supraspinatus tendon (beneath thetendon).

FIG. 8B illustrates a view of the articular side of the supraspinatustendon 28 near the point of insertion 30 on the humeral head 24. Thisview can be seen by a surgeon through the arthroscope when positionedbeneath the supraspinatus tendon. As can be seen in the illustration,the biceps tendon 29 is visible as it runs medially to the shoulderattachment. In treating the supraspinatus tendon with an implant overthe bursal side of the tendon, it is preferred to not interfere with thebiceps tendon by putting a staple or other attachment into this tendon.Therefore, as a first step in one method of the present disclosure, thelocation of the biceps tendon is marked so it is known when viewing thebursal side of the supraspinatus tendon. As illustrated in FIG. 8B, ashaft 302 of a marker assembly 300 has been inserted through the skin ofthe shoulder and the bursal side of the supraspinatus tendon 28 toproject into the space depicted with the location being adjacent thebiceps tendon 29 proximate the point of insertion 30. As depicted, thedelivery assembly has not been removed nor has the arms of the markerbeen deployed in the illustration. When deployed the arms will abut thesupraspinatus tendon on the articular side and be retained therein untilsufficient force is applied to flex the arms longitudinally and bepulled through the tissue.

In some methods, a second marker system 302 is used to mark a secondpoint medial of first marker. This is illustrated in FIG. 8C which showsa shaft 302 penetrating the bursal side of the supraspinatus tendon 28and adjacent the biceps tendon 29 at a location medial to the firstmarker. As depicted, the delivery assembly has not been removed nor hasthe arms of the marker been deployed in the illustration. When deployedthe arms will abut the supraspinatus tendon on the articular side and beretained therein until sufficient force is applied to flex the armslongitudinally.

FIG. 8D shows the shoulder as it appears on the skin surface with thetwo marker systems 300 inserted. The two points of insertion define aline that runs parallel to the biceps tendon under the supraspinatustendon which indicates an area where the implant should not be locatedor attached to avoid interfering with the biceps tendon. FIG. 8E showstwo of three incision ports that can be made relative to the markersystems 300. A first port can be located on the posterior side of theshoulder for inserting the arthroscope (not shown). A second port, theinferior lateral port 391 is made for insertion of the implant deliverysystem. A third port, or superior lateral port 392 is made for insertionof devices that are used to attach the implant to the tendon and bone.

A view of the bursal side of the supraspinatus tendon 28 with markersprojecting therethrough is illustrated in FIG. 8F. The drawing indicatesa clear visible line at the frontal margin of the supraspinatus tendonin line with the markers. Due to other tissue and ligaments in the areathis is not visible to the surgeon through the arthroscope. Therefore,the markers, as placed while viewing the biceps tendon from thearticular side delineate the front edge of where one would want to placethe implant.

With the front edge location of the implant delineated, the next step inone method of the present disclosure is placement and attachment of theguidewire. As illustrated in FIG. 8G, with the width of the implantselected for the tendon known, the first fixed point is located adistance D plus an additional distance X in the posterior direction fromthe line identified by the two markers 308. In some embodiments thedistance D is one-half of the width of the implant plus a distance X ofabout 2 mm. in the posterior direction from the line defined by the twomarkers 308. Further, the longitudinal distance between an implantmounted on the delivery system used and the guidewire port on thedelivery shaft is known. In the illustrated method, using onerepresentative delivery system, it is known that the longitudinallocation of the first fixed point should be at the insertion point. Asthe implant is delivered, it will then extend proximally down the arm ofthe patient from the line defined by the insertion point by about 5 mm.,which assures the implant extends over the point of insertion and isaffixed to the humeral head 24. As illustrated in FIG. 8G, a guidewire172 having a screw 183 for a tissue retention member is placed at theidentified first fixed point.

FIG. 8H illustrates the guidewire 172 after attachment to the humeralhead 24 proximate the point of insertion 30 and located posterior to theline defined by the markers 308 by a distance of one-half the width ofthe implant to be delivered plus about 2 mm. The implant delivery system60 is then tracked over the guidewire 172 into the vicinity of theimplant site as depicted in FIG. 8I. The delivery shaft is then extendedto expose the implant distally of the sheath, which is illustrated inFIG. 8J. The entire delivery system is urged distally so that theguidewire port is proximate the first fixed point where the guidewire isattached to the bone. As indicated in FIG. 8J, this assures the proximaledge of the implant extends a distance Y beyond the point of insertion30 and can be affixed to the humeral head 24. In some embodiments thedistance Y is about 5 mm. beyond the point of insertion 30 and assuresthe implant can be affixed to the humeral head 24.

Referring now to FIG. 8K, the next step in one method includes deployingthe implant spreader arms 120, 122 to unfurl the implant and hold itagainst the tendon 28. Once unfurled, the implant 50 can be rotatedabout the first fixed point (guidewire attachment to the bone) so thatthe front edge is generally parallel to the line defined by the twomarkers 308. As next shown in FIG. 8L, the implant 50 can be attached inmultiple locations to the supraspinatus tendon 28 using staples 51. Oncethe medial edge is attached, the implant delivery system can bepartially retracted while being used to smooth and pull the implant downand make sure it lays flat against the tendon while more staples areinserted into the tendon. In FIG. 8M, it is illustrated that the arms120, 122 may then be closed while the implant delivery system 60 isremoved from the treatment site. Referring to FIG. 8M, prior toattaching the rest of the implant, the guidewire 172 is removed in thisembodiment as it is located under the edge of the implant. The guidewiredelivery shaft 202 is placed over the guidewire and engages the screwhead to remove the guidewire. Once removed, additional staples can beinserted in the tendon and in the bone along with removal of the markers308.

While exemplary embodiments of the present invention have been shown anddescribed, modifications may be made, and it is therefore intended inthe appended claims and subsequently filed claims to cover all suchchanges and modifications which fall within the true spirit and scope ofthe invention.

What is claimed is:
 1. An implant delivery system for delivering asheet-like implant, the implant delivery system comprising: a deliveryshaft having a proximal end and a distal end defining a generallylongitudinal direction; an implant retainer assembly proximate thedistal end of the delivery shaft configured to releasably couple asheet-like implant thereto for positioning the sheet-like implant at atreatment site; an implant spreader assembly proximate the distal end ofthe delivery shaft, the implant spreader assembly having a plurality ofarms rotatable from a first closed position to a second open position,wherein in the second open position the plurality of arms spread animplant positioned on the implant retainer assembly; and, a guidewireport proximate the distal end of the delivery shaft for receiving aguidewire therethrough, wherein the guidewire port location ispositioned in known relation to an implant when placed on the implantretainer assembly.
 2. The delivery system of claim 1, further includinga sheath disposed about the implant spreader assembly, the sheath andimplant spreader assembly being slidable relative to each other in adirection generally parallel to a longitudinal axis of the deliveryshaft such that the implant spreader assembly can be exposed distal ofthe sheath.
 3. The delivery system of claim 2, further comprising asheet-like implant releasably coupled to the implant retainer assembly,wherein in the closed position the sheet-like implant fits within thesheath and in the open position the sheet-like implant is expanded tocover a treatment site.
 4. The delivery system of claim 3, wherein inthe closed position the sheet-like implant is in a rolled configuration.5. The delivery system of claim 3, wherein the sheet-like implantextends tautly between the arms of the implant spreader when the armsare in the open position.
 6. The delivery system of claim 1, wherein theimplant retainer assembly comprises a center post disposed proximate thedistal end of the delivery shaft and a mating surface having alongitudinally extending groove generally parallel and spaced from thecenter post wherein the mating surface cooperates with the center postto retain the implant when it is slidably disposed therebetween bydefining a slot that is dimensioned to receive the sheet-like implant.7. The delivery system of claim 1, wherein the delivery shaft provides aguidewire lumen in fluid communication with the distal guidewire portfor slidably receiving a proximal portion of a guidewire therein.
 8. Animplant positioning and delivery kit comprising: a guidewire including adistal portion having a tissue fixation member for releasably couplingthe guidewire to bone and a proximally extending wire portion; animplant delivery system including a delivery shaft having a proximal endand a distal end defining a generally longitudinal direction wherein animplant spreader assembly is located proximate the distal end of thedelivery shaft, the implant spreader assembly having a plurality of armsrotatable from a closed position to an open position wherein in the openposition the plurality of arms spread an implant at a treatment site,the implant delivery system further including a guidewire port proximatethe distal end of the delivery shaft for receiving a proximal end of theguidewire therethrough.
 9. The kit of claim 8, further comprising animplant retainer assembly proximate the distal end of the delivery shaftconfigured to releasably couple a sheet-like implant thereto forpositioning the sheet-like implant at a treatment site.
 10. The kit ofclaim 9, further including a sheath disposed about the implant spreaderassembly, the sheath and implant spreader assembly being slidablerelative to each other in a direction generally parallel to alongitudinal axis of the delivery shaft such that the implant spreaderassembly can be exposed distal of the sheath.
 11. The kit of claim 10,further comprising a sheet-like implant releasably coupled to theimplant retainer assembly, wherein in the closed position the sheet-likeimplant fits within the sheath and in the open position the sheet-likeimplant is expanded to cover a treatment site.
 12. The kit of claim 9,wherein the implant retainer assembly comprises a center post disposedproximate the distal end of the delivery shaft and a mating surfacehaving a longitudinally extending groove generally parallel and spacedfrom the center post wherein the mating surface cooperates with thecenter post to retain the implant when it is slidably disposedtherebetween by defining a slot that is dimensioned to receive thesheet-like implant.